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A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder. | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder.

A Multicenter, Randomized, Double-Blind Parallel Group Placebo-Controlled Phase III, Efficacy and Safety Study of 3 Fixed Dose Groups of TC-5214 (S-mecamylamine) as an Adjunct to an Antidepressants in Patients With Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy

NCT01197508•AstraZeneca

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like a medicine tablet or capsule, but contains no active medicine) is safe and effective when taken together with another antidepressant.

Detailed Description

A Multicenter, Randomized, Double-Blind Parallel Group Placebo-Controlled Phase III, Efficacy and Safety Study of 3 Fixed Dose Groups of TC-5214 (S-mecamylamine) as an Adjunct to an Antidepressants in Patients with Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Provision of signed and dated informed consent before initiation of any study-related procedures.
•The patient must have a clinical diagnosis of major depressive disorder (MDD) with inadequate response to no more than one antidepressant.
•Outpatient status at enrollment and randomization.

Exclusion Criteria

•Patients with a lifetime history of bipolar disorder, psychotic disorder or post-traumatic stress disorder.
•Patients with a history of suicide attempts in the past year and/or seen by the investigator as having a significant history of risk of suicide or homicide.
•History of renal insufficiency or impairment or conditions that could affect absorption or metabolism of investigational product.

Locations (87)

Research Site

Buenos Aires, Buenos Aires F.D., Argentina

Research Site

Mendoza, Mendoza Province, Argentina

Research Site

Ciudad Autonoma Bs As, Cba, Argentina

Research Site

Dublin, Argentina

Research Site

Rio de Janeiro, Rio de Janeiro, Brazil

Research Site

Novi Iskar, Bulgaria

Research Site

Rousse, Bulgaria

Research Site

Santiago, Chile, Chile

Research Site

Antofagasta, Chile

Research Site

Providencia Santiago, Chile

Key Dates

Start Date

September 1, 2010

Primary Completion Date

January 1, 2012

Completion Date

January 1, 2012

Last Updated

April 11, 2014

Enrollment

696

ACTUAL participants

Conditions

Major Depressive Disorder

Interventions

TC-5214

DRUG

Placebo

DRUG

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 11, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder.

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

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